Multiple-Ascending Dose Study

Phase 1

Completed

• Conditions: Depression
• Interventions: Drug: BMS-820836; Drug: Placebo

• Registration Number: NCT00892840
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to determine the safety and tolerability of BMS-820836 after multiple doses

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-02
• Study First Submitted QC: 2009-05-04
• Study First Posted: 2009-05-05
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-10
• Last Update Posted: 2011-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Panels 1-6: Healthy Male Subjects
• Panel 7: Females
• Ages 21 to 55, inclusive
• Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive
• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria

• Any major surgery within 4 weeks of study drug administration
• History of cholecystectomy
• History of glaucoma or a confirmed intraocular pressure indicative of glaucoma at screening. (Normal IOP <21 mmHg)
• Confirmed QTc (Fridericia) value ≥ 450 msec
• Confirmed QT ≥ 500 msec
• Confirmed PR ≥ 210 msec
• Confirmed QRS ≥ 120 msec
• Confirmed resting supine systolic blood pressure > 140 mmHg
• Confirmed resting supine diastolic blood pressure > 90 mmHg
• Confirmed resting heart rate < 45 bpm or > 100 bpm
• Orthostatic vital sign changes (ie., a decrease in systolic blood pressure from supine to standing > 40 mmHg and an increase in heart rate from supine to standing > 20 bpm) or symptoms of orthostasis
• History of peppermint allergies
• Exposure to any investigational drug or placebo within 12 weeks of study drug administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Panels 1 to 7 (BMS-820836 or Placebo)	Placebo	-
Panels 1 to 7 (BMS-820836 or Placebo)	BMS-820836	-

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of BMS-820836 following multiple-dose administration	Within 27 days (+/- 2 days) of first dose

Secondary Outcome Measures

Name	Time	Method
To assess the pharmacodynamics of BMS-820836	Within 27 days of first dose

Trial Locations

Locations (1)

Local Institution; 🇸🇪 Uppsala, Sweden